(198 days)
The ADVIA Centaur FT4 Immunoassay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in serum or plasma (heparinized or EDTA) using the ADVIA Centaur and ADVIA Centaur XP Systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid diseases.
The ADVIA Centaur FT4 assay is a competitive immunoassay using direct, chemiluminescent technology. Free thyroxine in the patient sample competes with acridinium ester-labeled T4 in the Lite Reagent for a limited amount of biotinylated polyclonal rabbit anti-T4 antibody that is bound to avidin that is covalently coupled to paramagnetic particles in the Solid Phase. There is an inverse relationship between the concentration of free thyroxine in the sample and relative light units (chemiluminescence).
Here's a breakdown of the acceptance criteria and study information for the ADVIA Centaur FT4 Immunoassay, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document describes the performance characteristics without explicitly stating pre-defined "acceptance criteria" but rather demonstrates substantial equivalence to a predicate device. For the purpose of this analysis, we can infer acceptance criteria as demonstrating comparable performance to the predicate device within reasonable experimental variation.
Table of Acceptance Criteria (Inferred) and Reported Device Performance
| Performance Characteristic | Inferred Acceptance Criteria (Comparable to Predicate Device) | ADVIA Centaur FT4 Performance (New Device) | Predicate Device (ACS:180 FrT4) Performance |
|---|---|---|---|
| Imprecision (Total CV%) | Comparable total CV% across various FT4 levels | 0.37 ng/dL: 11.2% | 0.58 ng/dL: 4.86% |
| 0.71 ng/dL: 4.85% | -- | ||
| 1.31 ng/dL: 3.98% | 1.42 ng/dL: 1.92% | ||
| 3.35 ng/dL: 4.07% | 3.37 ng/dL: 3.55% | ||
| 5.32 ng/dL: 4.02% | -- | ||
| 9.68 ng/dL: 6.53% | -- | ||
| (Study #2) 0.72 ng/dL: 4.16% | |||
| (Study #2) 1.47 ng/dL: 4.58% | |||
| (Study #2) 3.01 ng/dL: 4.44% | |||
| Specificity (% Cross Reactivity) | Very low cross-reactivity ( |
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.